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What Do Importers Need to Know About FSVP



Standard FSVP requirements include, but are not limited to:

  • conducting hazard analyses for imported food
  • evaluating the food and the foreign supplier
  • determining and performing supplier verification activities
  • taking corrective actions (when necessary)
  • ensuring importer identification at entry
  • maintaining records

In general, the importer will need to obtain assurances that its supplier is producing food using processes and procedures that provide the same level of public health protection as those required under the preventive controls requirements, or under the produce safety regulation, as well as assurances that the food is not adulterated and not misbranded with respect to allergen labeling.

For the purposes of FSVP, the importer is the U.S. owner or consignee of an article of food offered for import into the U.S.

If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. Agent such as ITB HOLDINGS LLC, or representative of the foreign owner or consignee, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.

Keep in mind that the United Parcel Service of America Inc (UPS), Deutsche Post AG (DHL), and FedEx Corporation (FedEx), will always request similar consent form.

An Importer of Record (IOR), as defined by the U.S. Customs and Boarder Protection (CBP), may be the same as the FSVP Importer, but is not necessarily.

Who Must Comply with the FSVP Rules

The requirements of the FSVP rules apply to businesses either in the U.S. or any other country, that are required to register with FDA as food facilities because they manufacture or process, pack, or hold food for consumption in the U.S. Namely:

  • Supplier
  • Manufacturer
  • Warehouse
  • Exporter
  • Importer of Record (IOR)
  • FSVP Importer.

However, there is an exemption or modified requirement for manufacturing, processing, packing, or holding of a dietary supplement covered by the Current Good Manufacturing Practices (CGMP).

Are also subject to CGMP, ingredients for dietary supplements, infant formula, beverages (including alcoholic beverages and bottled water), fruits and vegetables, fish and other seafood products, dairy products, baked goods, snack foods, candy, acid, acidified, and low-acid canned foods, as well as game meat.

Foreign Suppliers in Countries with Comparable or Equivalent Food Safety Systems

The United States and certain countries have entered into Food Safety Systems Recognition Arrangements (SRA).

Therefore, importers of certain foods from foreign suppliers located in those countries who are in good compliance standing with those authorities, are not required to comply with standard FSVP requirements.

Currently, Canada, Australia and New Zealand, are the only countries that have signed SRA with the FDA, for the purpose of Foreign Supplier Verification Program (FSVP).

When the food is not intended for further manufacturing or processing and the importer chooses to follow the modified requirements, the importer must document that the foreign supplier is in, and under the regulatory oversight of the recognized foreign food safety system, and must determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority.

Food from Very Small Suppliers

Who Is a Very Small Importer or Small Foreign Supplier?

  • Annual sales of less than $500,000 with at least half the sales to consumers or to local retailers or restaurants
  • Averaging less than $1,000,000 in both sales plus the market value of food that is manufactured, processed, packed, or held without sale (e.g., held for a fee)
  • Per year during the 3-year period preceding the current calendar year

If your company meets the eligibility requirements for a very small importer or an importer who is importing food from certain small foreign suppliers, written hazard analysis and evaluation of supplier’s performance, are not required.

You must document your eligibility for very small importer (VSI) status before initially importing food and thereafter on an annual basis by December 31 of each calendar year. You must document the supplier’s eligibility for small foreign supplier status before initially importing food and thereafter on an annual basis by December 31 of each calendar year.

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What’s included:

• Use of qualified individual to conduct FSVP activities
• Hazard analysis
• Food and supplier evaluation
• Foreign supplier verification
• Corrective actions
• Recordkeeping


Be ready to provide:

  • DUNS Numbers (Manufacturer, Exporter, U.S. Importer)
  • FDA Registration Numbers (Manufacturer, Exporter, U.S. Importer)
  • Labels to verify FDA Compliance
  • Certificates of Analysis, which must be issued by FDA Registered and Accredited Labs
  • Hazard Analysis Critical Control Point (HACCP) plans, Global Food Safety Initiative (GFSI) schemes, or
    other food defense and food safety programs to verify the safety of food being imported into the United States
  • Letter of Assurance from manufacturers, suppliers, and foreign authorities

A Foreign Supplier Verification Program (FSVP) Qualified Individual is a person who has the education, training, or experience (or a combination thereof) necessary to perform an activity required by the FSVP rule, and can read and understand the language of any records.

Because the appearance of the importer’s FSVP violations causes the food to be subject to Detention without Physical Examination (DWPE) under an Import Alert (a.k.a. Red List), the foreign supplier is not responsible for demonstrating that the conditions that gave rise to the appearance of the violations have been resolved. 

Nevertheless, it is possible that foreign suppliers may contact FDA offices seeking information about removal from the Red List. If this occurs, the FDA offices would direct the foreign suppliers to contact the relevant importers.

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